FDA Adverse Event Malfunction Summary report: N

ENDOTAK RELIANCE

MDR report key: 4883225 · Received July 1, 2015

Report

Report Number: 2124215-2015-07134
Event Type: Malfunction
Date Received: July 1, 2015
Date of Event: May 4, 2015
Report Date: May 4, 2015
Manufacturer: CPI - DEL CARIBE
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND COMPETITOR DEVICE EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS AT ROUTINE FOLLOW UP. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CONSIDERATIONS FOR LEAD TESTING/MEASUREMENTS OBTAINED WITH COMPETITOR DEVICES AND ADVISED PERFORMING ISOMETRIC MANIPULATIONS WHILE TESTING IMPEDANCE MEASUREMENTS AND POTENTIALLY DELIVERY OF A COMMANDED SHOCK TO DETERMINE THE TRUE SHOCK IMPEDANCE VALUE. ALL OTHER LEAD PARAMETERS WERE NOTED WITHIN NORMAL LIMITS. INFORMATION WAS LATER RECEIVED INDICATING SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO INCREASE IN THE FIRST MONTH OF IMPLANT STABILIZING AT APPROXIMATELY 120 OHMS. REPROGRAMMING THE UPPER LIMIT OF THE SHOCK IMPEDANCE ALERT HAS BEEN REQUESTED OF THE DEVICE MANUFACTURER TO ALLOW FOR CONTINUED MONITORING OF THE PATIENT. SHOULD IMPEDANCE MEASUREMENTS OF 170 OHMS OR HIGHER BE OBSERVED THE PATIENT WILL UNDERGO DEFIBRILLATION THRESHOLD (DFT) TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
424987	ENDOTAK RELIANCE	IMPLANTABLE LEAD	LWS	CPI - DEL CARIBE	0181

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR			4471\| 0181\| MISMATCH